Josh Disbrow
Analyst · Maxim Group
Thank you, Robert, and welcome, everyone. I'm pleased to be speaking with you following the achievement of yet another set of key milestones during the quarter, achievements which were made possible by the initiatives we undertook more than two years ago to reposition Aytu as a growing specialty pharmaceutical company focused on commercializing novel therapeutics with an aim towards driving consistent operating cash-flow. In fact, Q1 was our first-quarter with positive net income in the company's history and our sixth consecutive quarter of positive adjusted EBITDA. Beyond the positive net income and continued positive adjusted EBITDA, we saw key constructive trend lines during the quarter for both our ADHD and Pediatric product lines. ADHD script levels are well-above the normalized trend lines prior to the supply shortages and our Pediatric portfolio saw its first sequential revenue growth that we've reported in the last five quarters. This renewed growth directly results from the initiatives we put in-place to improve coverage, redirect promotional resources and reposition our products in the marketplace, and they are producing results. I'll touch more on the positive trends we're seeing in just a moment. Also, of note in today's announcement is that with the Consumer Health business sale completed and any historical impact now classified as discontinued operations, we have taken the final steps to align our operations going-forward through the implementation of a new series of organizational changes focused on optimizing operations and driving near-term cash-flow. The optimization efforts are expected to further reduce operating expenses by at least $2 million annually. I'll come back to this in just a moment as both Mark Oki, our outgoing CFO; and Ryan Selhorn, our newly appointed CFO, are both on the call to provide some comments and answer any questions. So here are the Q1 key headlines. Positive net income for the first time in company history, our sixth consecutive quarter of positive adjusted EBITDA, positive trend lines for both our ADHD and Pediatric portfolios, the implementation of a new series of organizational changes focused on optimizing operations and driving near-term cash-flow, which again are expected to further reduce operating expenses by at least $2 million annually. And all of this is done against the backdrop of a balance sheet that has $20.1 million in cash at the end of September, up slightly from the most recent quarter. I continue to be very pleased with the progress we've made. Okay. So let's jump into a few of the trends within each of our portfolios, starting with ADHD. For the quarter, net revenue for the ADHD portfolio, again, that's Adzenys XR-ODT and Cotempla XR-ODT was up 11% sequentially and up 1% compared to the prior year period. There are a few moving parts here, so I want to make sure we sift through all of this. As we communicated in the press release, we experienced an improvement in our gross-to-net this quarter as a result of a reduction of an accrued rebate liability related to the ADHD portfolio. This was the resolution of a multi-year rebate dispute with the payer over unauthorized rebates on our ADHD products, which had previously reduced our net revenue in prior periods for which we've been carrying a liability. The resolution resulted in an increase of net revenue of $3.3 million during the quarter and a reduction of that liability that we've been carrying on our balance sheet for the past few years. Clearly, this is a positive for Aytu stockholders and we consider this a significant win. Now let's look at prescriptions. As most of you are aware and most pronounced in the March 2023 quarter, there was a series of significant market-wide shortages that impacted the supply of Adderall and other ADHD stimulant medications. This caused massive product shortages across the country. Fortunately, Aytu supply was never impacted and we therefore realized a short-term benefit from the supply shortages across the competitive product lines that they were facing. The positive benefit to Aytu is that our scripts ramped-up rather quickly throughout much of calendar 2023, but started to normalize during the first-half of calendar 2024. The flux of scripts written for Adzenys and Cotempla during this time was great for Aytu, not only from a net revenue and script trend standpoint, but it also connected more patients and doctors with our brands and company as a whole. Clearly, we recognize that not all patients would stay on Adzenys or Cotempla and for some time, it'd be a temporary bridge for them back to their previous medication. But it was also our hope and frankly, our expectation that we would transition some of these patients longer-term to medications and that is exactly what we see happening. I'll put some specific numbers to this. In the first-quarter of fiscal 2022, 91,000 scripts were written for our ADHD brands, while in Q1 of 2023, that number was 90,000 even, so a pretty standard baseline. Due to the shortages, that number jumped all the way up to 115,000 in Q1 of fiscal 2024. Today, in the just reported Q1 of fiscal 2025, so the quarter-ending September, our ADHC scripts were 99,000. And while this is down from a year-ago first-quarter when the stimulant shortage was in full effect, it's up a full 10% over the normalized baseline Q1 levels in fiscal 2021 -- excuse me, 2022 and 2023. So we are clearly growing the baseline, but this growth is masked year to year when you look at the supply shortage surge from which we benefit. These apples-to-apples comps will likely continue for a number of couple of quarters before the growth will be evident on the top-line. But hopefully by us breaking out these details the way we have, you can understand that we've actually gained market-share and we continue to grow scripts over our baseline numbers. So this has been very encouraging to us. We're excited to see continued growth. Okay. So let's transition now to the Pediatric side. As we communicated, our Pediatric portfolio a while back was impacted by payer changes that occurred in mid-calendar 2023, so this impacted revenue for Pediatric brands. Since that time, we've been putting numerous initiatives into place around expanded resourcing in a targeted and very efficient way as we sought to secure improved reimbursement for both of our antihistamine, carbonoxamine as well as our multivitamin franchise. And as a result of these efforts, we’ve seen a significant increase in coverage as well as in script uptake, which has been very encouraging. In particular, we've increased our covered lives in areas that were previously lost due to some of the payer changes. Also, and perhaps more importantly, in areas where we didn't have coverage, we've seen some very exciting payer wins and we're resourcing those areas and already seeing results. We've seen good early traction by way of customer ordering, physician prescribing and pharmacy dispensing. This has resulted in positive momentum and this drove 54% sequential revenue growth for the Pediatric portfolio. Clearly, we are still down versus the same quarter last year, but if the current initiatives and the results hold as we expect they will, we should see not only sequential growth, but also year-over-year growth improvements here later this year. I said this last quarter and I think it bears repeating that it took us two or so quarters to put in-place all of the moves necessary to first halt these declines in coverage. And then second, fine-tune the promotional activities necessary to get back to growth on the Pediatric side. Fortunately, we think we are back on-track and look-forward to the positive contributions that our Pediatric product-line can bring to Aytu and its stockholders. That said, and even with the Pediatric products not back to the level that we could think they can ultimately get to, we drove our sixth consecutive quarter of positive adjusted EBITDA and net income and we believe with additional growth back, we're well-positioned to grow adjusted EBITDA and generate positive operating cash-flow moving forward. With both our ADHD and Pediatric portfolios trending in a positive direction, which should become only more pronounced in the quarters ahead once the year-over-year comparables become a bit more apples-to-apples. This top-line progress will be coupled with a dramatically improved and lower ongoing operating cost base. You should expect our expenses to continue to drop further in the quarters to come. This financial discipline is set against the backdrop of a balance sheet that is $20 million in cash, putting us in a position to have a very strong fiscal 2025. As I turn it over to review the financials in more detail, and as I mentioned in the beginning, by virtue of implementing these optimization strategies, we say goodbye to two highly experienced executives to who we are very grateful, Mark Oki and Russ McMahen, along with some additional members of our team. Mark has been a key executive member in driving aspects of the company's transformation over the last two-plus years, including the growth of our ADHD portfolio, our consolidation towards a commercial Rx-focused company and the implementation of overall process improvements, which has positioned us well as we move into this next phase of growth. With this being Mark's last earnings call with Aytu, I want to personally and publicly thank him for his steadfast leadership at Aytu in partnership with me as we made these many important changes throughout the organization. I thank Mark and I wish him well in his future endeavors. While most of our investors know Mark well from your interactions with him over the past few years, some of you may not be -- someone you may not be as familiar with, but who warrants a similar acknowledgement as Russ McMahen, our Senior Vice President of Research and Development. Russ has been an instrumental member of the Aytu management team since the Neos Therapeutics acquisition in 2021 and was a pivotal member of the team responsible for bringing both Adzenys and Cotempla through the development process into the market. Russ has been the constant professional through this time of transition, and I similarly want to wish him well and thank him for all he's done to get us to this point as the transition of manufacturing out of our Texas facility is essentially complete. Russ is expected to transition into a consulting role to ensure that we retain access to his expertise and technical and historical knowledge. With Mark's departure, taking the reins at CFO will be Ryan Selhorn, our current Executive Vice President of Finance and Business Optimization. Ryan joined Aytu in 2020 and has over 21 years of experience across finance, accounting, business development, business integrations and operations and has served as a public company CFO at numerous life sciences companies. I look-forward to his continued leadership moving forward and I'm excited to welcome him to the CFO position here at Aytu. Now let me turn the call over to Mark Oki to provide a few words before Ryan covers the financials in more detail. Mark?